Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

NCT04101331 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AFM13-202
• Study Type: interventional
• Target: 108
• Locations: 10 countries
• Sites: 69

Brief Summary

This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

Conditions

Peripheral T Cell Lymphoma; Transformed Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate Assessed by Independent Review Committee Based on PET-CT

  Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

  Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).

Secondary Outcomes (16)

• Overall Response Rate Assessed by Investigator Based on PET-CT

  Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

• Overall Response Rate Assessed by Investigator Based on CT

  Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

• Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT

  Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

• Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT

  Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

• Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT

  Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

Study Arms (1)

Cohort A

EXPERIMENTAL

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

Drug: AFM13

Interventions

AFM13 DRUG

weekly intravenous infusions of 200mg

Cohort A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed CD30-positive PTCL (most subtypes allowed) or TMF per the revised World Health Organization 2016 classification (Swerdlow, 2016) by central assessment.
• Cohorts A and B (PTCL cohorts): measurable by the modified Lugano Classification (Cheson, 2014); measurable disease of ≥1.5 cm diameter by computed tomography (CT), assessed locally for eligibility. Note: fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) recommended, if possible.
• Cohort C (TMF cohort): measurable by the Olsen Criteria (Olsen, 2011) including at least 1 cutaneous lymphoma lesion ≥2 cm in diameter, assessed locally for eligibility.
• Patients must have relapsed or refractory disease AND the following:
• Cohorts A and B (PTCL): patients must have received at least 1 prior line of systemic therapy. For patients with systemic ALCL, patients must have failed or be intolerant to brentuximab vedotin \[BV\]; Adcetris®
• Cohort C (TMF): patients must have received at least 1 prior line of systemic therapy; and have exhausted systemic therapies with regular approval for their disease

You may not qualify if:

• Patients with the following subtypes of lymphoma: T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; Chronic lymphoproliferative disorder of NK cells; Aggressive NK-cell leukemia; Extranodal NK-/T-cell lymphoma; Indolent T-cell lymphoproliferative disorder of the GI tract:
• Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Patients who have had a transplant \>3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD).
• Requirement for systemic immunosuppressive therapy, e.g. GvHD therapy, \<12 weeks prior to the first dose of study drug.
• Prior treatment with AFM13

Sponsors & Collaborators

• Affimed GmbH: lead

Study Sites (69)

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

Birmingham, Alabama, 35294, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California Los Angeles (UCLA) Health

Los Angeles, California, 90404, United States

Location

Emory University Clinic/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Ochsner Clinic Foundation/Precision Cancer Therapies Program

New Orleans, Louisiana, 70121, United States

Location

University of Michigan Health | Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Center for Lymphoid Malignancies

New York, New York, 10019, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Flinders Medical Centre

Bedford Park, Australia

Location

Monash Health-Monash Medical Centre

Clayton, Australia

Location

Concord Repatriation General Hospital

Concord, Australia

Location

Gosford Hospital

Gosford, Australia

Location

Linear Clinical Research

Nedlands, Australia

Location

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, France

Location

Centre Hospitalier Universitaire de Brest

Brest, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

CHU Pontchaillou

Rennes, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH

Essen, Germany

Location

University Hospital Leipzig

Leipzig, Germany

Location

Universitaetsmedizin Mainz

Mainz, Germany

Location

Rotkreuzklinikum Muenchen

München, Germany

Location

Ist.Ematologia E Oncologia Medica L.E A.Seragnoli

Bologna, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

Brescia, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Italy

Location

Azienda Ospedaliera Niguarda Ca' Granda

Milan, Italy

Location

Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna

Ravenna, Italy

Location

Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku

Gdynia, Poland

Location

Pratia MCM Krakow

Krakow, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

Warsaw, Poland

Location

Instytut Hematologii i Transfuzjologii, Klinika Hematologii

Warsaw, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

Wroclaw, Poland

Location

Republic Hospital n.a. V.A. Baranov

Petrozavodsk, Russia

Location

First State Saint-Petersburg Pavlov Medical University

Saint Petersburg, Russia

Location

GUZ Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Location

Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

Saint Petersburg, Russia

Location

Saratov State Medical University

Saratov, Russia

Location

Regional Clinical Hospital

Tula, Russia

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Duran I Reynals Hospital Catalan Institute Of Oncology

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

Barcelona, Spain

Location

Institut Catala d' Oncologia Girona

Girona, Spain

Location

Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

Madrid, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Institut Catala d'Oncologia Tarragona

Tarragona, Spain

Location

Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division

Ankara, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara

Ankara, Turkey (Türkiye)

Location

Gazi University Faculty of Medicine, Department of Internal Diseases

Ankara, Turkey (Türkiye)

Location

Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi

Ankara, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih

Istanbul, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, Turkey (Türkiye)

Location

Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division

İzmit, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi

Samsun, Turkey (Türkiye)

Location

Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi

Tekirdağ, Turkey (Türkiye)

Location

KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

AFM13

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Affimed GmbH

trials@affimed.com

+49 621 560030

Study Officials

• Karenza Alexis, MD

  Affimed Inc.

  STUDY DIRECTOR

• Won Seog Kim, Dr

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Steven Horwitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: November 13, 2019
• Primary Completion: May 11, 2022
• Study Completion: January 11, 2024
• Last Updated: November 5, 2024
• Results First Posted: June 5, 2023

Record last verified: 2024-11

Locations

PL (5); AU (6); FR (5); ES (10); TU (10); RU (6); IT (5); US (13); KR (5); DE (4)